Gastric CancerPhase 2NCT03104283
Apatinib for the Elderly Advanced Gastric Cancer
A Phase 2 study testing Apatinib in people with Gastric Cancer, run by Affiliated Hospital of Qinghai University at 5 sites in China.
Trial summary
The purpose of our study is to assess the efficacy and safety of apatinib in elderly advanced gastric cancer patients, and to find the relationship between the expression of VEGFR-2 and efficacy of apatinib treatment. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Apatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 5 sitesChina
- Study dates
- 5 Jun 2017to 2 Jun 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elderly patients (aged ≥ 60 years) with histologically confirmed advanced adenocarcinoma of the stomach or gastroesophageal junction;
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
- Progression with or intolerance to one or more lines of chemotherapy;
- At least one measurable lesion as defined by RECIST 1.1;
- With acceptable hematologic, cardiac, hepatic, pulmonary and renal function;
- Can take apatinib orally;
- Estimated life expectancy ≥ 3 months.
Who cannot join
- Patients cannot take apatinib orally for any reason;
- Patients with uncontrolled central nervous system (CNS) metastases;
- Patients with massive hydrothorax or ascites;
- Proteinuria 2+ or 24-hour urinary protein ≥ 1g;
- Newly-happened traumatism or pathological fracture;
- Estimated life expectancy ˂ 3 months;
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- Received chemotherapy in the past 28 days before enrollment;
- Patients with uncontrolled blood pressure on medication (≥ 140/90 mmHg);
- Patients with bleeding tendency, receiving thrombolytics or anticoagulants, receiving intravenous antibiotic treatment, had received bevacizumab or other VEGF TKIs before, or with other primary malignancy (except basal cell skin cancer or cervical carcinoma in situ).
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Affiliated Hospital of Qinghai University
Xining, Qinghai, 810000
People's Hospital of Qinghai Province
Xining, Qinghai, 810000
Qinghai Red Cross Hospital
Xining, Qinghai, 810000
the Fifth People's Hospital of Qinghai Province
Xining, Qinghai, 810000
Yangquan No.1 People's Hospital
Yangquan, Shanxi, 045000
About this study
Official title: A Multicenter, Single-arm, Phase Ⅱ Clinical Trial of Apatinib Monotherapy in Elderly Patients With Advanced Gastric Cancer(GC)
The purpose of our study is to assess the efficacy and safety of apatinib in elderly advanced gastric cancer patients, and to find the relationship between the expression of VEGFR-2 and efficacy of apatinib treatment.
Read the detailed description
The trial is funded by Chinese Society of Clinical Oncology-Beijing Xisike Clinical Oncology Research Fundation. The trial is prepared to be registered on the clinicaltrail.gov.
Quality assurance plan: Every participant is enrolled or excluded by two practiced investigators. And two investigators participate in all steps of the trail, including the record of the data, which is compared by the investigators. If the data is consistent, the investigators would record the data; if not, the data would be checked and decided by the two investigators. All the steps and data are site monitored and audited by the staff of research and financial department of Affliated Hospital of Qinghai University.
Data check: The investigators compare data entered into the registry against predefined rules for range or consistency with other data fields in the registry.
Source data verification: The investigators assess the accuracy, completeness, or representativeness of registry data by comparing the data to external data sources, including medical records and electronic case report forms.
Data dictionary that contains detailed descriptions of each variable used by the registry, including the source of the variable, coding information, and normal ranges if relevant.
Standard Operating Procedures to address registry operations and analysis activities, such as participants recruitment, data collection, data management, data analysis, reporting for adverse events, and change management. All registry operations would be done according to specific steps, and by two practiced investigators.
Sample size assessment to specify the number of participants or participant years necessary to demonstrate an effect. According to the formula to differ advantages and disadvantages, the investigators need at least 47 participants to take part in the trail. The investigators can recruit about 20 participants every year according to previous experiences, so the investigators should recruit about two years.
Plan for missing data: The investigators would collect as much data as possible, and the investigators exclude the participants who cannot cooperate on recruitment. And the investigators manage situations according to statistical principles where variables are reported as missing, unavailable, non-reported, uninterpretable, or considered missing because of data inconsistency or out-of-range results.
Statistical analysis plan: Statistical analyses would be performed by using SPSS software, version 13.0 (SPSS Inc., IL, USA). Survival analysis would be performed using Kaplan-Meier methodology. Fisher's exact test would be used to analyze the efficacy of treatment. Cox proportional hazards model would be used for multivariate analysis. The level of significance is defined as P < 0.05.
- Conditions
- Gastric Cancer
- Being tested
- Apatinib
- Keywords
- apatinib, gastric cancer, elderly patients
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApatinibDrug
Also called Apatinib group
take apatinib orally until disease progression or appearance of unbearable toxicity
| Study group | Role | What they receive |
|---|---|---|
| Apatinib Group | Experimental | take apatinib orally (500mg/d or 250mg/d, once a day, continuously ) Receives: Drug: Apatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
PFS was defined to be the time from registration to the date of disease progress sion or death resulting from any cause.
Measured: 1 year
Secondary outcomes (3)
Objective response rate (ORR)
ORR was defined as the proportion of eligible patients who achieved a confirmed complete response(CR )or partial response (PR) by RECIST 1.1 criteria evaluated by the investigators.
Measured: 1 year
Disease control rate (DCR)
DCR was defined as the proportion of patients who achieved CR, PR and stable disease (SD) for at least 8 weeks.
Measured: 1 year
Overall survival (OS)
OS was defined to be the time from registration to the date of death resulting from any cause or the last follow-up visit.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2017
- Study start5 Jun 2017
- Primary completion1 Dec 2019
- Study completion2 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Qinghai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiuda Zhao, Affiliated Hospital of Qinghai University
- Investigators
- Jiuda Zhao, M.D., Principal investigator, Affiliated Hospital of Qinghai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03104283
- Sponsor's protocol ID
- AHQU-2017001
- Status last verified
- Mar 2022
- First submitted
- 1 Apr 2017
- Last updated
- 15 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Single-arm, Phase Ⅱ Clinical Trial of Apatinib Monotherapy in Elderly Patients With Advanced Gastric Cancer(GC)
- ClinicalTrials.gov ID
- NCT03104283
- Acronym / sponsor ID
- AHQU-2017001
- Conditions
- Gastric Cancer
- Keywords
- apatinib, gastric cancer, elderly patients
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Affiliated Hospital of Qinghai UniversityUniversity, hospital or other
- Study start
- 5 Jun 2017 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 2 Jun 2020 (actual)
- First posted
- 7 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of our study is to assess the efficacy and safety of apatinib in elderly advanced gastric cancer patients, and to find the relationship between the expression of VEGFR-2 and efficacy of apatinib treatment.
Detailed description
The trial is funded by Chinese Society of Clinical Oncology-Beijing Xisike Clinical Oncology Research Fundation. The trial is prepared to be registered on the clinicaltrail.gov.
Quality assurance plan: Every participant is enrolled or excluded by two practiced investigators. And two investigators participate in all steps of the trail, including the record of the data, which is compared by the investigators. If the data is consistent, the investigators would record the data; if not, the data would be checked and decided by the two investigators. All the steps and data are site monitored and audited by the staff of research and financial department of Affliated Hospital of Qinghai University.
Data check: The investigators compare data entered into the registry against predefined rules for range or consistency with other data fields in the registry.
Source data verification: The investigators assess the accuracy, completeness, or representativeness of registry data by comparing the data to external data sources, including medical records and electronic case report forms.
Data dictionary that contains detailed descriptions of each variable used by the registry, including the source of the variable, coding information, and normal ranges if relevant.
Standard Operating Procedures to address registry operations and analysis activities, such as participants recruitment, data collection, data management, data analysis, reporting for adverse events, and change management. All registry operations would be done according to specific steps, and by two practiced investigators.
Sample size assessment to specify the number of participants or participant years necessary to demonstrate an effect. According to the formula to differ advantages and disadvantages, the investigators need at least 47 participants to take part in the trail. The investigators can recruit about 20 participants every year according to previous experiences, so the investigators should recruit about two years.
Plan for missing data: The investigators would collect as much data as possible, and the investigators exclude the participants who cannot cooperate on recruitment. And the investigators manage situations according to statistical principles where variables are reported as missing, unavailable, non-reported, uninterpretable, or considered missing because of data inconsistency or out-of-range results.
Statistical analysis plan: Statistical analyses would be performed by using SPSS software, version 13.0 (SPSS Inc., IL, USA). Survival analysis would be performed using Kaplan-Meier methodology. Fisher's exact test would be used to analyze the efficacy of treatment. Cox proportional hazards model would be used for multivariate analysis. The level of significance is defined as P < 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Apatinib Group | Experimental | Drug: Apatinibtake apatinib orally (500mg/d or 250mg/d, once a day, continuously ) |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Elderly patients (aged ≥ 60 years) with histologically confirmed advanced adenocarcinoma of the stomach or gastroesophageal junction;
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
- Progression with or intolerance to one or more lines of chemotherapy;
- At least one measurable lesion as defined by RECIST 1.1;
- With acceptable hematologic, cardiac, hepatic, pulmonary and renal function;
Key exclusion criteria (9 listed)
- Patients cannot take apatinib orally for any reason;
- Patients with uncontrolled central nervous system (CNS) metastases;
- Patients with massive hydrothorax or ascites;
- Proteinuria 2+ or 24-hour urinary protein ≥ 1g;
- Newly-happened traumatism or pathological fracture;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ApatinibAlso: Apatinib grouptake apatinib orally until disease progression or appearance of unbearable toxicity | Drug | Apatinib Group |
Primary outcome
Progression-free survival (PFS)
Time frame: 1 year
PFS was defined to be the time from registration to the date of disease progress sion or death resulting from any cause.
3 secondary outcomes
Objective response rate (ORR)
Time frame: 1 year
Disease control rate (DCR)
Time frame: 1 year
Overall survival (OS)
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiuda Zhao, M.D. principal investigator
Affiliated Hospital of Qinghai University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Apatinib in people with Gastric Cancer, run by Affiliated Hospital of Qinghai University at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2022.